Cellectar Biosciences to Highlight Strategic Initiatives for 2026 at Upcoming Biotech Showcase during 44th Annual JP Morgan Healthcare Conference

Rhea-AI Summary

Cellectar (NASDAQ: CLRB) outlined 2026 priorities at the Biotech Showcase and plans to submit a Conditional Marketing Authorization (CMA) application to the EMA for iopofosine I 131 in Waldenstrom’s macroglobulinemia in 3Q 2026, targeting potential European approval in early 2027. The company noted FDA Breakthrough Designation and a confirmed traditional accelerated approval pathway in the U.S. for iopofosine I 131, highlighted Phase 2 CLOVER WaM final results and subset analyses, and expects to begin dosing in the Phase 1b CLR 125 TNBC study in 1Q 2026 with interim data due mid-2026. Cellectar reported raising approximately $15.2M to support pipeline and regulatory work.

Positive

• EMA SAWP feedback supports CMA filing for iopofosine I 131
• FDA granted Breakthrough Designation for iopofosine I 131
• Confirmed U.S. accelerated approval pathway for iopofosine I 131
• Presented extended progression-free survival in CLOVER-2 pHGG
• Raised approximately $15.2M to support development and milestones
• Planned CLR 125 Phase 1b dosing in 1Q 2026 with mid-2026 interim data

Negative

• CMA submission timing targets 3Q 2026 with approval not until early 2027
• Key outcomes depend on successful patient enrollment for multiple trials
• Regulatory approvals remain conditional and subject to agency review
• Company continuing to seek non-dilutive funding, indicating ongoing capital needs

News Market Reaction – CLRB

-6.95%

3 alerts

-6.95% News Effect

-$985K Valuation Impact

$13M Market Cap

1.0x Rel. Volume

On the day this news was published, CLRB declined 6.95%, reflecting a notable negative market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $985K from the company's valuation, bringing the market cap to $13M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Capital raised 2025: $15.2 million CMA filing timing: 3Q 2026 EU approval goal: Early 2027 +3 more

6 metrics

Capital raised 2025 $15.2 million Raised through financings and warrant exercises to support development

CMA filing timing 3Q 2026 Planned EMA Conditional Marketing Approval submission for iopofosine I 131 in WM

EU approval goal Early 2027 Targeted timeframe for potential European conditional marketing approval

CLR 125 first dosing 1Q26 Anticipated first patients in Phase 1b CLR 125 TNBC study

CLR 125 interim data Mid-2026 Expected interim Phase 1b data readout in TNBC

Biotech Showcase dates January 12–15, 2026 Conference where 2026 initiatives will be highlighted

Market Reality Check

Price: $2.90 Vol: Pre‑news volume of 11,175...

low vol

$2.90 Last Close

Volume Pre‑news volume of 11,175 is very light at only 0.16x the 20‑day average of 69,208. low

Technical Shares at $3.31 are trading below the 200‑day MA of $5.83 and are 83.93% under the 52‑week high.

Peers on Argus

Biotech peers were mixed: EDSA down 3.21%, THAR down 3.32%, while LSTA, PULM, an...

1 Down

Biotech peers were mixed: EDSA down 3.21%, THAR down 3.32%, while LSTA, PULM, and SYBX rose between 0.83% and 3.07%. Momentum scanners only flagged GOVX moving down 13.96% without news, offering limited evidence of a coordinated sector move relative to CLRB’s largely flat pre‑news trading.

Historical Context

5 past events · Latest: Dec 16 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 16	Supply agreement	Positive	-0.6%	Multi‑year Ionetix deal securing Ac‑225 and At‑211 isotope supply.
Nov 13	Earnings & update	Positive	-18.0%	Q3 2025 results plus CMA/NDA plans and pipeline progress disclosures.
Nov 06	Earnings date notice	Neutral	+2.7%	Announcement of timing for Q3 2025 results and investor call.
Oct 27	Regulatory designation	Positive	-10.3%	FDA Rare Pediatric Disease Designation for iopofosine I 131 in r/r pHGG.
Oct 14	Preclinical data	Positive	+1.6%	Positive AACR preclinical results for CLR 225 in pancreatic cancer models.

Pattern Detected

Recent positive clinical and regulatory updates have often been followed by negative 24‑hour price reactions, suggesting a tendency for the stock to sell off on good news.

Recent Company History

Over the last few months, CLRB has advanced multiple radiotherapeutic programs and regulatory paths. In October–November 2025, it reported promising preclinical data for CLR 225, gained Rare Pediatric Disease Designation for iopofosine I 131 in r/r pHGG, and confirmed EMA and FDA pathways for Waldenström macroglobulinemia alongside Q3 2025 results. A December 2025‑12‑16 supply agreement secured long‑term access to Ac‑225 and At‑211. Today’s 2026 strategic roadmap continues that progression, emphasizing regulatory filings, first‑in‑human work, and capital discipline.

Market Pulse Summary

The stock moved -7.0% in the session following this news. A negative reaction despite the strategic ...

Analysis

The stock moved -7.0% in the session following this news. A negative reaction despite the strategic roadmap would fit prior instances where favorable updates, such as designations or supply deals, were followed by selling. The plan depends on executing an EMA submission by 3Q 2026, achieving early 2027 conditional approval, and generating mid‑2026 CLR 125 data, all of which require sustained funding and trial performance. Disappointment or concern about these execution and capital‑raising needs could have amplified downside moves.

Key Terms

european medicines agency, scientific advice working party, conditional marketing approval, break through designation, +4 more

8 terms

european medicines agency regulatory

"Following Guidance from the European Medicines Agency’s (EMA) Scientific Advice Working Party"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

scientific advice working party regulatory

"Agency’s (EMA) Scientific Advice Working Party (SAWP) Regarding Iopofosine I 131"

A scientific advice working party is a group of independent experts convened by a regulatory authority to give targeted guidance on the design, testing, and evidence needed for a medical product to win approval. For investors, their advice can change a development plan like a road map being revised by engineers: it affects likely timelines, required studies, costs, and the chance a product will reach the market, which in turn influences a company’s value.

conditional marketing approval regulatory

"Expects to Submit for Conditional Marketing Approval in Europe in 3Q 2026"

A conditional marketing approval is a temporary regulatory ok for a medicine or medical product to be sold based on promising but incomplete evidence, granted because the product addresses an unmet medical need. It matters to investors because it lets the product generate revenue earlier—like a provisional driver's license allowing limited driving—while carrying extra risk that regulators may later require more studies or revoke approval if further data are unsatisfactory.

break through designation regulatory

"U.S. Food and Drug Administration (FDA) granted Break Through Designation (BTD) for iopofosine"

A regulatory status granted to an experimental medical product that shows early clinical evidence of substantial improvement over existing treatments for a serious condition, intended to speed its development and regulatory review. It matters to investors because it can act like VIP fast‑tracking—reducing time and uncertainty on the path to market, improving the odds of earlier revenue and higher valuation, while not guaranteeing approval or commercial success.

accelerated approval regulatory

"Confirmed traditional accelerated approval pathway with the FDA for iopofosine I 131 in WM"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

nda regulatory

"Advance NDA preparations for U.S. accelerated approval"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

triple negative breast cancer medical

"CLR 125 for the Treatment of Triple Negative Breast Cancer in 1Q26"

Triple negative breast cancer is a type of breast cancer that lacks three common markers used to identify and target the disease, making it more challenging to treat. It tends to grow and spread more quickly than other forms, which can lead to more aggressive outcomes. Its complexity can impact medical research and treatment developments, influencing investor interest in healthcare companies working on new therapies.

auger-emitting medical

"CLR 125, an Auger-emitting iodine-125 program for the treatment of triple-negative breast cancer"

Auger-emitting describes a radioactive substance that releases very low-energy electrons (Auger electrons) when its atoms decay; those electrons travel only a few nanometers, delivering damage in an extremely localized spot. For investors, this matters because such agents are used in targeted medical diagnostics and therapies where precision can improve effectiveness and reduce side effects, so successful development or regulatory approval can materially affect a biotech company's clinical and commercial prospects.

AI-generated analysis. Not financial advice.

Following Guidance from the European Medicines Agency’s (EMA) Scientific Advice Working Party (SAWP) Regarding Iopofosine I 131 for the Treatment of Waldenstrom’s Macroglobulinemia (WM), Expects to Submit for Conditional Marketing Approval in Europe in 3Q 2026

Plans to Present Final Results and Subset Analysis of WM Patients from the Phase 2 CLOVER WaM Clinical Study of Iopofosine I 131

Anticipates Dosing of First Patients in Phase 1b Study of CLR 125 for the Treatment of Triple Negative Breast Cancer in 1Q26 with Interim Data Mid-2026

FLORHAM PARK, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the development of targeted radiotherapeutics for cancer, today announces plans to highlight the company’s 2026 strategic initiatives at the upcoming Biotech Showcase, taking place January 12-15, 2026, in San Francisco during the 44^th Annual JP Morgan Healthcare Conference. James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 1:30 pm Pacific Time.

2025 Achievements

• Received feedback from the SAWP supporting a Conditional Marketing Authorization (CMA) filing for iopofosine I 131 in WM based upon our CLOVER WaM study
• U.S. Food and Drug Administration (FDA) granted Break Through Designation (BTD) for iopofosine I 131 in relapsed/refractory WM
• Confirmed traditional accelerated approval pathway with the FDA for iopofosine I 131 in WM
• Presented compelling data from the CLOVER-2 Phase 1b study in relapsed/refractory pediatric high-grade glioma (pHGG), demonstrating extended progression-free survival and favorable safety profile
• Initiated a Phase 1b clinical study for CLR 125, an Auger-emitting iodine-125 program for the treatment of triple-negative breast cancer (TNBC)
• Strengthened supply chain through strategic supply agreements for our next generation Auger- and alpha-emitting radiotherapeutics
• Raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones
  
  

CEO Commentary

“Our priorities are clear: secure European conditional marketing approval for iopofosine I 131 for WM in early 2027 with commercialization to follow, further validate our PDC platform by executing on our Phase 1b study evaluating CLR 125 for TNBC, and advance our regulatory strategy with the FDA for iopofosine I 131 approval in the U.S. With an established iopofosine I 131 regulatory strategy for both EMA and FDA, and promising data across our pipeline, we are entering 2026 with strong momentum and multiple opportunities,” said James Caruso, president and CEO of Cellectar. “We believe these initiatives position Cellectar to deliver meaningful therapies for patients and create significant value for shareholders.”

2026 Strategic Initiatives

• Regulatory Milestones:
  • Submit CMA application to EMA for iopofosine I 131 in WM in 3Q 2026, with potential European market approval in early 2027
  • Advance NDA preparations for U.S. accelerated approval
• Clinical Development:
  • Enroll patients in the Phase 1b study of CLR 125 in TNBC with interim data expected in mid-2026
  • Present final findings and subset analysis from the CLOVER WaM Phase 2 study of iopofosine I 131
  • Prepare actinium-based CLR 225 for first-in-human trials in pancreatic cancer
• Pipeline Expansion:
  • Progress additional PDC-based radiotherapeutics into preclinical and IND-enabling studies
• Partnerships:
  • Evaluate strategic collaborations for commercialization of iopofosine I 131
• Financial Strategy:
  • Continue disciplined capital management and explore non-dilutive funding opportunities
    
    

“Looking ahead, we are focused on receiving a conditional marketing approval in 2027 from the EMA impacting approximately thirty countries, which collectively possess a larger WM population than the U.S. In parallel, we remain committed to advancing our regulatory strategy with the FDA fully understanding the tremendous incremental value it potentially represents for all Cellectar stakeholders. The FDA-recommended post-BTKi indication positions iopofosine I 131 as a treatment option as early as the second line, substantially expanding the available patients in the U.S. market. Additionally, we are actively recruiting patients for our Phase 1b study evaluating CLR 125, our Auger-based radiotherapeutic for the treatment of TNBC, which builds on strong preclinical data showing growth inhibition and tumor volume reduction in this challenging-to-treat cancer,” concluded Mr. Caruso.

Mr. Caruso’s Biotech Showcase presentation will be live webcast and can be accessed HERE. A replay of the presentation will be available on the Events section of the company’s Investor Relations website.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments that deliver improved efficacy and better safety.

The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope) for the treatment of hematologic and solid tumor cancers such as Waldenstrom’s macroglobulinemia (WM) and pediatric high grade gliomas; CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeting solid tumors, such as triple negative breast, lung and colorectal cancers; CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors with significant unmet need, such as pancreatic cancer; and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory WM and multiple myeloma (MM), non-Hodgkin’s lymphomas and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough Therapy, six Orphan Drug, five Rare Pediatric Drug and two Fast Track Designations for various cancer indications. The European Medicines Agency (EMA) has also granted PRIME and orphan drug designations for the treatment of WM.

For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.

Forward Looking Statements Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. We will require additional funding to fully execute our strategy. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarterly period ended September 30, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com

FAQ

When will Cellectar (CLRB) submit the EMA CMA application for iopofosine I 131?

Cellectar expects to submit the CMA application in 3Q 2026 with potential European approval in early 2027.

What U.S. regulatory designations does iopofosine I 131 have for WM (CLRB)?

iopofosine I 131 has received FDA Breakthrough Designation and a confirmed traditional accelerated approval pathway in the U.S.

When will Cellectar (CLRB) begin dosing patients in the CLR 125 Phase 1b TNBC study?

Cellectar anticipates dosing the first patients in 1Q 2026 with interim data expected in mid-2026.

What results will Cellectar (CLRB) present from the CLOVER WaM Phase 2 study?

The company plans to present final results and a subset analysis of WM patients from the CLOVER WaM Phase 2 study.

How much financing did Cellectar (CLRB) raise to support its pipeline?

Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones.